Chronic Obstructive Pulmonary DiseaseNCT06332417
Combined Effects of Ba-Duan-Jin Based Deep Breathing Exercises and Forced Expiratory Technique
A study testing Ba-Duan-Jin Based Deep Breathing Exercises and FET (Forced Expiratory Technique) in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study will be a randomized control trial. A total of 68 patients will be recruited and randomly assign to the experimental group or the control group in a 1:1 ratio. Participants in the experimental group will receive a 8-week Ba-duan jin exercise training intervention along with Forced Expiratory Technique at… Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Ba-Duan-Jin Based Deep Breathing Exercises and FET (Forced Expiratory Technique)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Feb 2024to 15 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both Genders
- Diagnosis of COPD: Participants must have a documented diagnosis of Chronic Obstructive Pulmonary Disease (COPD) based on established clinical criteria (such as GOLD guidelines)
- Participants should be between 40 and 55 years old
- Participants should be in a stable condition, free from exacerbations or respiratory infections for at least four weeks prior to the study enrollment.
- Participants must be physically able to participate in Ba-Duan-Jin based deep breathing exercises.
Who cannot join
- Individuals with significant comorbidities such as asthma, pulmonary fibrosis, bronchiectasis, or lung cancer
- Participants with severe cardiovascular conditions, such as recent myocardial infarction, unstable angina, or uncontrolled hypertension, which could limit exercise participation
- Individuals with severe cognitive impairment or psychiatric conditions preventing them from understanding and following the exercise program
- Individuals with severe physical impairments unrelated to COPD, hindering their ability to perform exercises or assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Effects of Ba-Duan-Jin Based Deep Breathing Exercises and Forced Expiratory Technique in Patients With Chronic Obstructive Pulmonary Disease
This study will be a randomized control trial. A total of 68 patients will be recruited and randomly assign to the experimental group or the control group in a 1:1 ratio. Participants in the experimental group will receive a 8-week Ba-duan jin exercise training intervention along with Forced Expiratory Technique at least 3 days a week and 30 minutes a day, while participants in the control group will be only given Forced Expiratory intervention and will be told to maintain their original lifestyle for 8 weeks along with standard COPD treatment.
Read the detailed description
This study will be a randomized control trial. A total of 68 patients will be recruited and randomly assign to the experimental group or the control group in a 1:1 ratio. Participants must have a documented diagnosis of Chronic Obstructive Pulmonary Disease (COPD) based on established clinical criteria (such as GOLD guidelines). Participants should be between 40 and 55 years old. Participants should be in a stable condition, free from exacerbations or respiratory infections for at least four weeks prior to the study enrollment. Participants in the experimental group will receive a 8-week Ba-duan jin exercise training intervention along with Forced Expiratory Technique at least 3 days a week and 30 minutes a day, while participants in the control group will be only given Forced Expiratory intervention and will be told to maintain their original lifestyle for 8 weeks along with standard COPD treatment. All participants will continue with their prescribed medication. During this study time participants will be given instructions on how to perform the prescribed pulmonary exercises. After each exercise session the FEV1 and exercise capacity of the patients will be checked.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Ba-Duan-Jin Based Deep Breathing Exercises, FET (Forced Expiratory Technique)
- Keywords
- Pulmonary disease, Breathing Exercises, Ba-Duan Jin
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ba-Duan-Jin Based Deep Breathing ExercisesOther
Pressing Up to the Heavens: Deep inhales while raising arms, promoting lung expansion.
Drawing the Bow to Shoot the Eagle: Stretching exercises to improve flexibility and posture.
FET (Forced Expiratory Technique)Other
The forced expiratory technique sometimes referred to as a 'huff', is used to help force secretions (phlegm) up the throat so it can be removed via the mouth without the pain of coughing.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Ba-Duan-Jin Exercise + FET (Forced Expiratory Technique) Receives: Other: Ba-Duan-Jin Based Deep Breathing Exercises |
| Control Group | Active comparator | FET (Forced Expiratory Technique) only Receives: Other: FET (Forced Expiratory Technique) |
What is being measured
The primary outcome is the main question the study is designed to answer.
36-Item Short Form Survey (SF-36)
The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life.
It comprises 36 questions that cover eight domains of health:
- Limitations in physical activities because of health problems.
- Limitations in social activities because of physical or emotional problems
- Limitations in usual role activities because of physical health problems
- Bodily pain
- General mental health (psychological distress and well-being)
- Limitations in usual role activities because of emotional problems
- Vitality (energy and fatigue)
- General health perceptions Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high QOL
Measured: 8 Weeks
FEV1/FVC ratio
The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs. The normal value for this ratio is above 0.75-85, though this is age dependent.
Measured: 8 Weeks
Exercise Tolerance : 6 minute walk test
a patient can quickly walk back and forth in a 30-m (100-foot) corridor in a period of 6 min, referred to as the 6-min walk distance (6MWD).
Measured: 8 Weeks
Forced vital capacity (FVC)
Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible. It's measured by spirometry , which is a common breathing test to check lung function.
Measured: 8 Weeks
Forced expiratory volume (FEV1)
Forced expiratory volume (FEV1) calculates the amount of air that a person can force out of their lungs in 1 second. It's measured by spirometry , which is a common breathing test to check lung function.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start29 Feb 2024
- Primary completion5 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Faizan Hamid, MS-CPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332417
- Sponsor's protocol ID
- REC/RCR&AHS/23/0364
- Status last verified
- Jul 2024
- First submitted
- 4 Mar 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Ba-Duan-Jin Based Deep Breathing Exercises and Forced Expiratory Technique in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06332417
- Acronym / sponsor ID
- REC/RCR&AHS/23/0364
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Pulmonary disease, Breathing Exercises, Ba-Duan Jin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be a randomized control trial. A total of 68 patients will be recruited and randomly assign to the experimental group or the control group in a 1:1 ratio. Participants in the experimental group will receive a 8-week Ba-duan jin exercise training intervention along with Forced Expiratory Technique at least 3 days a week and 30 minutes a day, while participants in the control group will be only given Forced Expiratory intervention and will be told to maintain their original lifestyle for 8 weeks along with standard COPD treatment.
Detailed description
This study will be a randomized control trial. A total of 68 patients will be recruited and randomly assign to the experimental group or the control group in a 1:1 ratio. Participants must have a documented diagnosis of Chronic Obstructive Pulmonary Disease (COPD) based on established clinical criteria (such as GOLD guidelines). Participants should be between 40 and 55 years old. Participants should be in a stable condition, free from exacerbations or respiratory infections for at least four weeks prior to the study enrollment. Participants in the experimental group will receive a 8-week Ba-duan jin exercise training intervention along with Forced Expiratory Technique at least 3 days a week and 30 minutes a day, while participants in the control group will be only given Forced Expiratory intervention and will be told to maintain their original lifestyle for 8 weeks along with standard COPD treatment. All participants will continue with their prescribed medication. During this study time participants will be given instructions on how to perform the prescribed pulmonary exercises. After each exercise session the FEV1 and exercise capacity of the patients will be checked.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Ba-Duan-Jin Based Deep Breathing ExercisesBa-Duan-Jin Exercise + FET (Forced Expiratory Technique) |
| Control Group | Active comparator | Other: FET (Forced Expiratory Technique)FET (Forced Expiratory Technique) only |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both Genders
- Diagnosis of COPD: Participants must have a documented diagnosis of Chronic Obstructive Pulmonary Disease (COPD) based on established clinical criteria (such as GOLD guidelines)
- Participants should be between 40 and 55 years old
- Participants should be in a stable condition, free from exacerbations or respiratory infections for at least four weeks prior to the study enrollment.
- Participants must be physically able to participate in Ba-Duan-Jin based deep breathing exercises.
Key exclusion criteria (4 listed)
- Individuals with significant comorbidities such as asthma, pulmonary fibrosis, bronchiectasis, or lung cancer
- Participants with severe cardiovascular conditions, such as recent myocardial infarction, unstable angina, or uncontrolled hypertension, which could limit exercise participation
- Individuals with severe cognitive impairment or psychiatric conditions preventing them from understanding and following the exercise program
- Individuals with severe physical impairments unrelated to COPD, hindering their ability to perform exercises or assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ba-Duan-Jin Based Deep Breathing ExercisesPressing Up to the Heavens: Deep inhales while raising arms, promoting lung expansion. Drawing the Bow to Shoot the Eagle: Stretching exercises to improve flexibility and posture. | Other | Intervention group |
| FET (Forced Expiratory Technique)The forced expiratory technique sometimes referred to as a 'huff', is used to help force secretions (phlegm) up the throat so it can be removed via the mouth without the pain of coughing. | Other | Control Group |
Primary outcome
36-Item Short Form Survey (SF-36)
Time frame: 8 Weeks
The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life. It comprises 36 questions that cover eight domains of health: 1. Limitations in physical activities because of health problems. 2. Limitations in social activities because of physical or emotional problems 3. Limitations in usual role activities because of physical health problems 4. Bodily pain 5. General mental health (psychological distress and well-being) 6. Limitations in usual role activities because of emotional problems 7. Vitality (energy and fatigue) 8. General health perceptions Scores for the different domains are converted and pooled using a scoring key, for a total score indicating a range of low to high QOL
FEV1/FVC ratio
Time frame: 8 Weeks
The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs. The normal value for this ratio is above 0.75-85, though this is age dependent.
Exercise Tolerance : 6 minute walk test
Time frame: 8 Weeks
a patient can quickly walk back and forth in a 30-m (100-foot) corridor in a period of 6 min, referred to as the 6-min walk distance (6MWD).
Forced vital capacity (FVC)
Time frame: 8 Weeks
Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible. It's measured by spirometry , which is a common breathing test to check lung function.
Forced expiratory volume (FEV1)
Time frame: 8 Weeks
Forced expiratory volume (FEV1) calculates the amount of air that a person can force out of their lungs in 1 second. It's measured by spirometry , which is a common breathing test to check lung function.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Faizan Hamid, MS-CPPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ba-Duan-Jin Based Deep Breathing Exercises and FET (Forced Expiratory Technique) in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
36-Item Short Form Survey (SF-36) (time frame: 8 Weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.